CMC Regulatory Strategy Lead - Cell Therapy
Kite Pharma
Kite Pharma, Inc. is seeking a Regulatory CMC leader to drive end-to-end regulatory strategies for T-cell and LVV programs. You will shape governance for regulatory submissions, maintain lifecycle strategies, and partner with manufacturing to ensure compliant, scalable processes across development and commercialization. The role requires extensive experience in biotechnology CMC, with hands-on knowledge of autologous T-cell and LVV manufacturing, and a proven ability to navigate global health #J-18808-Ljbffr Kite Pharma, Inc.
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the CMC Regulatory Strategy Lead - Cell Therapy in El Segundo, CA vacancy
$218.06k - $327.09k
...ready to set the global regulatory vision for pioneering cell therapies and turn breakthrough science... ...for patients? This role leads high-impact programs... ...labeling. You will shape strategy for complex, visible programs... ...with clinical, CMC, safety and commercial strategies...RegulatoryHourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per weekAstraZeneca
Santa Monica, CA6 days ago$205.62k - $266.09k
...pioneering personalized CAR T-cell therapies have changed the paradigm.... ...Director, Global Value & Access Strategy (GVAS), Cell-therapy... ...to the Senior Director, GVA Lead, Lymphoma, Autoimmune and Solid... ...Affairs, HEOR/RWE, Commercial, Regulatory Affairs and regional Access...RegulatoryFull timeFor contractorsWork at officeLocal areaGilead Sciences
El Segundo, CA2 days ago- ...Kite, a Gilead subsidiary, seeks a Manager in Regulatory Affairs focused on Chemistry, Manufacturing, and Controls (CMC) for cell and gene therapies. The role involves preparing regulatory submissions, developing CMC strategies, and collaborating across functions to...Regulatory
Gilead Sciences
El Segundo, CA9 days ago - ...Senior Manager of Regulatory Affairs Chemistry, Manufacturing, and Controls (CMC) at Kite, a Gilead company, leading regulatory strategy for CAR T-cell therapies and lentiviral vector manufacturing across early-stage through commercial phases. Responsibilities Lead...Regulatory
Gilead Sciences
El Segundo, CA9 days ago $205.62k - $266.09k
...a Director of Global Value & Access Strategy for its cell-therapy autoimmune portfolio. The role involves... ..., collaborating with clinical, regulatory, and commercial teams to ensure payer... ...representative for autoimmune programs and lead cross-functional strategic...Regulatory- ...and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're... ...based/hybrid position. The Manager, Regulatory Affairs CMC is located in El Segundo, CA, Thousand... ...LVV) manufacturing, testing, control strategy, and lifecycle management.Contribute...RegulatoryFull timeContract workFor contractorsWork at officeLocal areaRemote workRelocationFlexible hours
GILEAD Sciences
Santa Monica, CA6 days ago - ...Senior Manager role supporting regulatory and chemistry, manufacturing, and controls (CMC) activities for Kite's cell therapy and CAR-T programs. The position manages complex submissions... ...and execute global CMC regulatory strategies aligned with program objectives and...Regulatory
Gilead Sciences
Santa Monica, CA9 days ago $143.23k - $185.35k
...pioneering personalized CAR T-cell therapies have changed the paradigm.... ...Senior Manager, Regulatory Affairs CMC supports and drives increasingly... ...execution of global regulatory strategies, supports end-to-end preparation... ...and submission quality.May lead or contribute to CMC RA sub...RegulatoryFull timeFor contractorsWork at officeLocal areaRemote workRelocationFlexible hoursShift workGILEAD Sciences
Santa Monica, CA3 days ago$143.23k - $185.35k
...breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not... ...onsite. Key Responsibilities Regulatory Strategy and Program Leadership Lead or support integrated global CMC regulatory strategies for both T-cell drug...RegulatoryFull timeFor contractorsWork at officeLocal areaRemote workRelocationFlexible hoursGilead Sciences
Santa Monica, CA17 days ago$186.23k - $279.35k
...AstraZeneca seeks a Director of Regulatory Affairs Strategy for cell therapy programs spanning oncology, immune-mediated, and rare diseases. This role shapes... ...submission milestones and maintenance activities Lead regulatory strategy and execution for Health Authority...Regulatory$267.91k - $401.87k
Within the AstraZeneca Cell Therapy Enterprise, our ambition is to realize the full potential... ...AstraZeneca’s Therapeutic Area Units. The Strategy and Commercial Executive Director, Cell... ...area within Cell Therapy. You will lead global commercial and strategic initiatives...Full timeTemporary workWork at officeFlexible hours3 days per weekAstraZeneca
Santa Monica, CA5 days ago$191.25k - $247.5k
...pioneering personalized CAR T-cell therapies have changed the paradigm.... ...Facilities and Equipment Quality Strategy and Technical Oversight,... ...consistent quality and regulatory outcomes. Strategic Quality... ...escalation, and approval. Lead network-wide harmonization and...RegulatoryFull timeFor contractorsLocal areaGilead Sciences
El Segundo, CA23 days ago$133.2k - $172.37k
...Manager, Regulatory Affairs CMC at Kite (Gilead Sciences) leads chemistry, manufacturing, and controls regulatory submissions for autologous CAR T-cell therapies in clinical development and commercial expansion... ...CMC lifecycle, regulatory strategy, and cross-functional...Regulatory$96k - $144k
...Engineer to advance late-stage cell therapy process development and... ...support, technology transfer, and regulatory documentation for autologous... ...operations and automation strategies for scalability and... ...sites Author and review CMC documentation including process...RegulatoryAstraZeneca
Santa Monica, CA6 days ago$96k - $144k
...Senior Process Engineer to support cell therapy process characterization and... ...operations and automation strategies to support scalability and compliance... ...facilities and platforms. Regulatory Support Contribute to authoring and reviewing CMC documentation, including cell...RegulatoryFull timeTemporary workShift workAstraZeneca
Santa Monica, CA5 days ago$138k - $207k
...Director, Late-Stage Cell Therapy Process Development, will... ...is responsible for leading a team of scientists and... ...BLA and global regulatory submissions. The successful... ...Analytical Development, and CMC teams to ensure robust... ...reports, and control strategy elements. Support...RegulatoryTemporary work- ...is seeking an Environmental Manager to lead our company-wide environmental function... ...the EHS organization. You will develop strategy, policies, and management systems, and provide... ...include permitting, due diligence, and regulatory strategy, along with building a scalable...Regulatory
- ...Santa Monica, CA, offers an internship in Med Affairs (Strategy and Communications) within Cell Therapy. You will contribute to high-impact projects, gain... ...medical education initiatives, and ensuring regulatory-compliant materials. #J-18808-Ljbffr American Society...RegulatoryInternship
$207k - $300k
...the industry’s most ambitious Cell Therapy portfolios, spanning... ...Site Head Cell Therapy will lead a large Site Quality support... ...budgetDevelops innovative Quality strategies with a sense of urgency to enable... ...relationship with the regulatory bodies, including dealing with...RegulatoryFull timeFor contractorsWork at office3 days per weekAstraZeneca
Santa Monica, CA6 days ago$231.99k - $347.98k
...Director of Global Marketing for its Cell Therapy Enterprise to develop commercial strategy and launch plans for a cell... ...Partner with Medical, Market Access, Regulatory, and Manufacturing teams to align... ...Demonstrated ability to lead multiple indications simultaneously...RegulatoryAstraZeneca
Santa Monica, CA9 days ago$115k - $168k
...risk infrastructure.As Risk & Compliance Lead, you will build and own Radiant's risk... ...operations, IT, security, finance, and regulatory teams.This is a high-visibility, largely... ...government and commercial).Design risk isolation strategies (both contractual and insurance-based)...RegulatoryLong term contractFull timeSummer workImmediate startRemote workFlexible hoursWeekend workRadiant Industries
El Segundo, CA2 days ago$231.99k - $347.98k
Within the AstraZeneca Cell Therapy Enterprise, our ambition is to realize... ...drive the global commercial strategy for the cell therapy... ...Clinical, Medical, Market Access, Regulatory, Manufacturing, Supply, and... ...is an advantage. Experience leading multiple indications...RegulatoryHourly payFull timeTemporary workWork at office3 days per weekAstraZeneca
Santa Monica, CA2 days ago$19 - $55 per hour
...and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not... ...Intern - Kite Development - Med Affairs (Strategy and Communications - Cell Therapy)... ...presentation of data, appropriate referencing, regulatory compliance, and alignment with...RegulatoryHourly payFull timeFor contractorsInternshipLocal areaRemote workRelocation- ...the design and business strategy for cutting‑edge... ...biologics, and advanced therapies. About HED We are a team... ...Monitor industry trends and regulatory changes to ensure... ...of emerging trends in cell and gene therapy, biologics... ...class biotech facilities. Lead design proposals for...Regulatory
- Cortica is seeking a Developmental Therapies Site Supervisor in California to lead a multidisciplinary team of SLPs, OTs, PTs, and Music Therapists. You... ...coordination, and advancing clinical quality while maintaining regulatory compliance in a pediatric setting. #J-18808-Ljbffr...Regulatory
- ...actively developing the technologies to make this possible, with the ultimate goal of enabling human life on Mars.STARLINK CONSUMER STRATEGY LEAD (FORECASTING)Starlink, our revolutionary satellite constellation, will deliver low-latency broadband internet worldwide. We are...Permanent employmentTemporary workWork experience placementWorldwideWeekend work
SpaceX
Hawthorne, CA4 days ago $267.91k - $401.87k
...AstraZeneca seeks a Strategy and Commercial Executive Director to lead end-to-end cell therapy strategy for defined indications, driving commercial initiatives and competitive intelligence across the Cell Therapy Enterprise. The role requires shaping portfolio strategy...- ...Scientist to support biomarker and translational strategy for CAR-T programs in Multiple Myeloma. You... ...Research and Clinical Development to elucidate CAR-T cell function and prognostic tool development. The role requires regulatory filing experience and the ability to...Regulatory
$138k - $207k
...deliver life-changing cell and gene therapies to patients. We are... ...will set the technical strategy for phase-appropriate... ..., and partner across CMC functions to ensure... ...serve as Analytical Lead for programs advancing... ...risks, timelines, and regulatory deliverables.Author analytical...RegulatoryFull timeTemporary workAstraZeneca
Santa Monica, CA4 days ago- ...pioneering personalized CAR T-cell therapies have changed the paradigm.... ...limited to):Develop and implement regulatory product strategiesRepresent... ...regulatory guidance and strategy including identifying and... ...requirementsServe as the US Regulatory Lead (USRL) for assigned...RegulatoryFull timeFor contractorsWork at officeLocal areaRemote workRelocationFlexible hours
GILEAD Sciences
Santa Monica, CA6 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to CMC Regulatory Strategy Lead - Cell Therapy. Be the first to apply!
Related searches
- regulatory contract El Segundo, CA
- regulatory engineer El Segundo, CA
- regulatory law El Segundo, CA
- regulatory El Segundo, CA
- food regulatory El Segundo, CA
- preferred therapy solutions El Segundo, CA
- therapy office El Segundo, CA
- therapy manager El Segundo, CA
- therapy El Segundo, CA
- group therapy El Segundo, CA